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Treats seizures associated with Lennox-Gastaut syndrome (LGS). ANDA 210039, held by Amneal. Clobazam.
As of Nov 14, 2026, ANDA 210039 (Clobazam), held by Amneal, was first approved by FDA on Oct 22, 2018, with 3 approved supplements and 0 published complete response letters.
First approved: Oct 22, 2018
Review: Standard
Supplements approved: 3
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Clobazam oral suspension is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. Clobazam oral suspension is a benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
